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June 23, 2014
08:02 EDTLGNDLigand announces presentation of data from Phase 1 study
Ligand Pharmaceuticals announced that data from a Phase 1 study of the selective estrogen receptor modulator lasofoxifene were featured in a poster presentation today at ICE/ENDO 2014 in Chicago. The presentation provided data from a first-in-human clinical study of lasofoxifene that was performed by Pfizer and recently analyzed by Ligand demonstrating the potent and prolonged effect of a single dose to increase circulating testosterone and gonadotropin levels in healthy young men. Highlights of the presentation include: In an investigator-blinded, randomized, placebo-controlled, single-ascending dose study involving 36 healthy male volunteers, lasofoxifene was well-absorbed after oral administration with peak plasma concentrations reached approximately 6 to 9 hours post-dose and a long elimination half-life of approximately 106 hours; There were no serious adverse events and no clinically significant changes in safety laboratory, vital signs or ECG assessments; Single oral doses of lasofoxifene of 1, 3, 10, 30 and 100 mg increased levels of testosterone; doses of 30 and 100 mg increased levels of T by more than 80%; Levels of luteinizing hormone and follicle-stimulating hormone were also elevated with single oral doses of 30 and 100 mg; Levels of T, LH and FSH peaked between 3 and 7 days post-dose and elevations induced by higher doses were maintained through at least 28 days; T levels plateaued at the high normal range of 30-40 nmol/L between 7 and 28 days post-dose regardless of lasofoxifene dose or LH levels.
News For LGND From The Last 14 Days
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July 30, 2015
09:01 EDTLGNDLigand enters license, supply agreement with Sanofi
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July 24, 2015
12:44 EDTLGNDAmgen announces FDA approval of expanded Kyprolis indication
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12:27 EDTLGNDFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
09:02 EDTLGNDLigand says Revolade recommended by CHMP for EU approval for SAA
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